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Lipoprotein MetabolismPhase 2NCT02514070

Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults

A Phase 2 study testing EPA-rich fish oil and DHA-rich fish oil in people with Lipoprotein Metabolism and PCSK9, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are substances found in foods such as cold-water fish and shellfish that are essential for good health. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Lipoprotein Metabolism, PCSK9, Proteomics
What is being tested?
EPA-rich fish oil and DHA-rich fish oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
30 Oct 2015to 23 Jul 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female participants 18 years of age or above.
  • Subject must be healthy, with no known history of cardiovascular disease.
  • Subject understands protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.

Who cannot join

  • Pregnancy, planned pregnancy (within the study period) or women currently breastfeeding.
  • Subjects with weight changes greater than 20% over the past 3 months.
  • Subjects planning a significant change in diet or exercise levels.
  • Subjects already consuming more than 1.5 g per day of Eicosapentaenoic Acid (EPA) or Docosahexaenoic Acid (DHA) in any form.
  • Subjects taking supplements or medications that affect lipoproteins for at least the past six weeks including fish oil supplements, bile-acid sequestrants, plant sterol supplements, fibrates, statins or Niacin.
  • Subjects diagnosed with cancer or IBD, or that have taken diarrhea inhibitors, laxatives or prebiotics in the week before stool sampling (optional), or antibiotics within 3 months before sampling.
Show all 22Show fewer
  • Subjects taking daily aspirin or other anti-platelet or anti-coagulants agents (Plavix).
  • History of prostate Cancer
  • Subjects with known bleeding disorders (for example, Hemophilia)
  • Known sensitivity or allergy to fish, shellfish or omega-3 fatty acids supplements
  • Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other conditions that could affect intestinal fat absorption
  • Subjects with any acute and life-threatening condition, such as prior sudden cardiac arrest, acute myocardial infarction (last three months), stroke, embolism
  • Liver enzymes (aspartate aminotransferase (AST) or alanine transaminase (ALT)) levels above 3x upper limit of normal
  • Subjects initiating new medications or patients on multiple medications may also be excluded according to investigator discretion
  • Subjects previously diagnosed with cardiac dysrhythmia
  • Subjects with clinically diagnosed hepatic disease (including but not limited to auto immune disease, hepatitis and cirrhosis)
  • Anticipated surgery during the study period
  • Blood donation in the last 2 weeks or planned blood donation during the study
  • Subjects requiring regular transfusions for any reason
  • Subjects may also be excluded for any reason that may compromise their safety or the accuracy of research data.
  • Subjects being treated with tamoxifen, estrogens, or progestins that have not been stable for >4 weeks.
  • Subjects that thyroid stimulating hormone (TSH) levels are greater than 1.5 x Upper Limit of Normal (ULN) or clinical evidence of hypothyroidism

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Background:

  • Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are substances found in foods such as cold-water fish and shellfish that are essential for good health. Researchers want to see the effect of two fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on metabolism. They may be beneficial to cardiovascular health.
Read more

Objective:

  • To understand the effects of EPA and DHA on metabolism.

Eligibility:

  • Healthy people ages 18 years or above with plasma triglyceride (a type of fat in the blood) levels of 100 mg/dL or higher

Design:

  • The study will last 20 to 24 weeks.
  • Participants will have 4 visits to the NIH Clinical Center. These will include:
  • Medical history
  • Physical Fasting blood and urine tests
  • CAVI tests: blood pressure is taken in the arms and legs, and the heart is monitored.
  • Participants will take an EPA/DHA dietary supplement. They will take 4 gel capsules, 3 times a day, for 6 or 7 weeks. Then they will not take the capsules for 8 to 10 weeks (a wash-out period). They will then take the capsules again for 6 or 7 weeks.
  • Participants will keep a food journal.
Read the detailed description

This is a novel randomized crossover, double-blinded pilot study that aims to investigate the effects of different omega-3 fatty acids, namely EPA and DHA, on lipoprotein metabolism. Subjects will be unblinded for performance of measurements after they complete the study. Subjects will receive EPA or DHA supplements for approximately 6 weeks with a wash out period of 8 weeks between the two arms of the study. The study consists of 4 outpatient visits when laboratory or research samples and CAVI tests will be performed. A 7-day food diary, pill count, and red cell membrane n-3 levels will be monitored to assess compliance.

Serum cholesterol is transported by lipoproteins, such as VLDL, LDL and HDL, which vary in their relationship to cardiovascular risk. LDL is proatherogenic, whereas HDL is cardio-protective. Fish oil supplementation, such as EPA and DHA, has been shown to reduce triglycerides. EPA supplementation has also been shown to lower LDL-C, whereas DHA can raise both LDL-C and HDL-C. These differential effects on lipoproteins may alter the cardiovascular protection afforded by fish oil supplementation. This study will test the hypothesis that EPA and DHA may differ in their LDL-C lowering ability because of differences in how they modulate plasma PCSK9 levels, which is a major determinant of LDL-C levels. In addition, we will assess other parameters related to lipoprotein composition and function that may impact the cardioprotective effect of EPA and DHA. Other reported beneficial effects of omega-3 fatty acid supplementation, such as decreased platelet coagulability, markers of inflammation and changes in guy microbiota, will also be monitored.

Being tested
EPA-rich fish oil, DHA-rich fish oil
Keywords
LDL-C, Omega-3 Fatty Acid, PCSK9, HDL-C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPA-rich fish oilDrug

    Also called Eicosapentaenoic acid (EPA) Fish Oil

    4 gel capsules, 3 times/day for 6 weeks

  • DHA-rich fish oilDrug

    Also called Docosahexaenoic acid (DHA) Fish Oil

    4 gel capsules, 3 times/day for 6 weeks

Study groups in NCT02514070
Study groupRoleWhat they receive
EPA-rich fish oil arm then DHA-rich fish oil armExperimentalSubjects randomized to the EPA-rich fish oil arm will take the equivalent to 3g of EPA /day (12 gel capsules/day) for 6 more or less 1 weeks and cross-over to the DHA-rich capsule arm
Receives: Drug: EPA-rich fish oil
DHA-rich fish oil arm then EPA-rich fish oil armExperimentalSubjects randomized to the DHA-rich fish oil arm will take the equivalent to 3g of DHA /day (12 gel capsules/day) for 6 more or less 1 weeks and cross-over to the EPA-rich capsule arm
Receives: Drug: DHA-rich fish oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma PCSK9 Levels at Baseline and End of 6 Week Intervention

    Measure plasma proprotein convertase subtilisin/kexin type 9 (PCSK9) level, at baseline, after 6 weeks of Eicosapentaenoic acid (EPA) or Docosahexaenoic acid (DHA) fish oil supplementation.

    Measured: baseline to 6 weeks of intervention

Secondary outcomes (1)

  1. Plasma Levels in Triglyceride, Cholesterol, and Lipoprotein From Baseline to 6 Weeks

    Measure plasma levels at baseline to 6 weeks of intervention for the following: triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), lipoprotein particle composition and size, and high-density lipoprotein (HDL) cholesterol efflux capacity.

    Measured: Baseline to 6 weeks of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2015 (estimated)
  2. Study start30 Oct 2015
  3. Primary completion23 Jul 2019
  4. Study completion23 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02514070
Sponsor's protocol ID
150173
Other IDs
15-H-0173
Status last verified
24 Jul 2019
First submitted
31 Jul 2015
Last updated
15 Jul 2021
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EPA-rich fish oil and DHA-rich fish oil in people with Lipoprotein Metabolism and PCSK9, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma PCSK9 Levels at Baseline and End of 6 Week Intervention (time frame: baseline to 6 weeks of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02514070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.

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